Back to resultsSafety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
Primary Purpose
Pneumococcal Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female toddlers ≥12 to <24 months of age at the time of consent
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
- 2 infant doses of Prevenar 13 prior to 12 months of age
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- Major known congenital malformation or serious chronic disorder
- Other chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation
Sites / Locations
- Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
- Lurko-Med Kft Hazi Gyermekorvosi Rendelo
- Elitance Duo Kft.
- Private practice - Dr. Várhelyiné Dr. Torday Judit
- Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet
- Mimiped Betéti Társaság
- Futurenest Klinikai Kutató Kft.
- Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság
- MICS Centrum Medyczne Toruń
- SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
- Przylądek Zdrowia
- Rodzinne Centrum Medyczne LUBMED
- IN-VIVO Bydgoszcz
- SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
- Pro Familia Altera Sp. z o.o.
- NZOZ Vita Longa Sp. z o.o.
- Przylądek Zdrowia
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
- Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
- Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
- Centrum Medyczne Pratia Poznan
- MICS Centrum Medyczne Toruń
- Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
- CHUS - Hospital Clinico Universitario
- Hospital Germans Trias i Pujol
- Hospital Sant Joan de Déu
- Hospital Sant Joan de Déu
- Hospital Universitari General de Catalunya
- EAP Osona Sud - Alt Congost S.L.P
- CHUS - Hospital Clinico Universitario
- Hospital Universitario HM Puerta del Sur
- Hospital Universitario HM Monteprincipe
- Grupo Pediatrico Uncibay
- Hospital de Nens de Barcelona
- Hospital General Universitario Gregorio Maranon
- Hospital General Universitario Gregorio Marañón
- Hospital Universitario 12 de Octubre
- Hospital Universitario HM Sanchinarro
- Grupo Pediatrico Uncibay
- Instituto Hispalense de Pediatria
- Instituto Hispalense de Pediatria
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
2-Dose 20vPnC Group
1-Dose 20vPnC Group
13vPnC Group
Arm Description
Pneumococcal conjugate vaccine (2 doses approximately 2 months apart)
Pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Outcomes
Primary Outcome Measures
Percentage of participants reporting prompted local reactions within 7 days after the last assigned vaccination in each group
Prompted local reactions after the last assigned vaccination in each group
Percentage of participants reporting prompted systemic events within 7 days after the last assigned vaccination in each group
Prompted systemic events after the last assigned vaccination in each group
Percentage of participants reporting adverse events (AEs) within 1 month after the last assigned vaccination in each group
AEs occurring from last vaccination to 1 month after the last vaccination in each group
Percentage of participants reporting serious adverse events (SAEs) within month after the last assigned vaccination in each group
SAEs occurring from last vaccination to 1 month after the last vaccination in each group
Percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes 1 month after the last assigned vaccination in each group
IgG concentrations 1 month after the last assigned vaccination
Secondary Outcome Measures
Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after the last assigned vaccination in each group
IgG GMCs 1 month after the last assigned vaccination
Percentages of participants with predefined serotype-specific IgG concentrations for the 13 matched serotypes 1 month after the last assigned vaccination in each group
IgG concentrations 1 month after the last assigned vaccination
Opsonophagocytic activity (OPA) GMTs 1 month after the last assigned vaccination in each in group
OPA GMTs 1 month after the last assigned vaccination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05408429
Brief Title
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
Official Title
A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13.
This study is being conducted in children who:
are between 12 to 23 months of age;
are healthy as determined by the study doctors;
have received 2 doses of Prevnar 13 during the first year in life.
Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study is partially masked. Participants randomized to receive 2 doses of 20vPnC will not have treatment masking. Participants randomized to receive 1 dose of 20vPnC or 13vPnC will have treatment masking.
Allocation
Randomized
Enrollment
356 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-Dose 20vPnC Group
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine (2 doses approximately 2 months apart)
Arm Title
1-Dose 20vPnC Group
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine
Arm Title
13vPnC Group
Arm Type
Active Comparator
Arm Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
20-valent pneumococcal conjugate vaccine
Intervention Description
20-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
13-valent pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of participants reporting prompted local reactions within 7 days after the last assigned vaccination in each group
Description
Prompted local reactions after the last assigned vaccination in each group
Time Frame
Day 7
Title
Percentage of participants reporting prompted systemic events within 7 days after the last assigned vaccination in each group
Description
Prompted systemic events after the last assigned vaccination in each group
Time Frame
Day 7
Title
Percentage of participants reporting adverse events (AEs) within 1 month after the last assigned vaccination in each group
Description
AEs occurring from last vaccination to 1 month after the last vaccination in each group
Time Frame
1 month after the last vaccination
Title
Percentage of participants reporting serious adverse events (SAEs) within month after the last assigned vaccination in each group
Description
SAEs occurring from last vaccination to 1 month after the last vaccination in each group
Time Frame
1 month after the last vaccination
Title
Percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes 1 month after the last assigned vaccination in each group
Description
IgG concentrations 1 month after the last assigned vaccination
Time Frame
1 month after the last vaccination
Secondary Outcome Measure Information:
Title
Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after the last assigned vaccination in each group
Description
IgG GMCs 1 month after the last assigned vaccination
Time Frame
1 month after the last vaccination
Title
Percentages of participants with predefined serotype-specific IgG concentrations for the 13 matched serotypes 1 month after the last assigned vaccination in each group
Description
IgG concentrations 1 month after the last assigned vaccination
Time Frame
1 month after the last vaccination
Title
Opsonophagocytic activity (OPA) GMTs 1 month after the last assigned vaccination in each in group
Description
OPA GMTs 1 month after the last assigned vaccination
Time Frame
1 month after the last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female toddlers ≥12 to <24 months of age at the time of consent
Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
2 infant doses of Prevenar 13 prior to 12 months of age
Exclusion Criteria:
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
Major known congenital malformation or serious chronic disorder
Other chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
City
Budapest
ZIP/Postal Code
1042
Country
Hungary
Facility Name
Lurko-Med Kft Hazi Gyermekorvosi Rendelo
City
Budapest
ZIP/Postal Code
1048
Country
Hungary
Facility Name
Elitance Duo Kft.
City
Budapest
ZIP/Postal Code
1188
Country
Hungary
Facility Name
Private practice - Dr. Várhelyiné Dr. Torday Judit
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Mimiped Betéti Társaság
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Futurenest Klinikai Kutató Kft.
City
Miskolc
ZIP/Postal Code
3527
Country
Hungary
Facility Name
Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság
City
Szigetvár
ZIP/Postal Code
7900
Country
Hungary
Facility Name
MICS Centrum Medyczne Toruń
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
City
Lomianki
State/Province
Mazowieckie
ZIP/Postal Code
05-092
Country
Poland
Facility Name
Przylądek Zdrowia
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
30-644
Country
Poland
Facility Name
Rodzinne Centrum Medyczne LUBMED
City
Lubon
State/Province
Wielkopolskie
ZIP/Postal Code
62-030
Country
Poland
Facility Name
IN-VIVO Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-048
Country
Poland
Facility Name
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
City
Dziekanów Leśny
ZIP/Postal Code
05-092
Country
Poland
Facility Name
Pro Familia Altera Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
NZOZ Vita Longa Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Przylądek Zdrowia
City
Krakow
ZIP/Postal Code
30-644
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawła II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
City
Poznan
ZIP/Postal Code
60-663
Country
Poland
Facility Name
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
City
Poznań
ZIP/Postal Code
60-663
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
MICS Centrum Medyczne Toruń
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie
City
Warszawa
ZIP/Postal Code
01-809
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-368
Country
Poland
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
A Coruña [LA Coruña]
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Universitari General de Catalunya
City
Sant Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
EAP Osona Sud - Alt Congost S.L.P
City
Centelles
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08500
Country
Spain
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15760
Country
Spain
Facility Name
Hospital Universitario HM Puerta del Sur
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28938
Country
Spain
Facility Name
Hospital Universitario HM Monteprincipe
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Grupo Pediatrico Uncibay
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29015
Country
Spain
Facility Name
Hospital de Nens de Barcelona
City
Barcelona
ZIP/Postal Code
08009
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Grupo Pediatrico Uncibay
City
Malaga
ZIP/Postal Code
29015
Country
Spain
Facility Name
Instituto Hispalense de Pediatria
City
Sevilla
ZIP/Postal Code
41012
Country
Spain
Facility Name
Instituto Hispalense de Pediatria
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471027
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
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